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Dexian · 1 day ago

Quality Engineer (Medical devices)

Cheswick, PA

Contract

Onsite

Mid, Senior Level

$64/hr - $68/hr

4+ years exp

Dexian is a leading provider of staffing, IT, and workforce solutions. They are seeking a Quality Engineer to lead supplier qualification activities for new components and processes in the manufacturing of medical devices, ensuring compliance with design and quality requirements.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Hiring Manager

Prathamesh Waghmode

Responsibilities

Lead supplier qualification activities for new components and processes to support production launch readiness of a new medical device

Plan, execute, and document component and process qualification activities

Review and interpret supplier documentation to support qualifications such as FAIs, pFMEAs, Control Plans, Process Flow Diagrams, IQ/OQ/PQs

Ensure supplier process capability meets design and quality requirements through capability studies (Cpk) and statistical analysis

Collaborate with R&D Mechanical and Electrical Design Engineers, and other internal stakeholders, to ensure supplier capabilities and manufactured parts align with design intent and resolve discrepancies

Serve as the quality interface between the R&D organization and selected suppliers

Qualification

Qualification methodologiesRegulated industry experienceSupplier relationship managementISO 13485 knowledgeISO 9001 knowledgeTechnical problem solvingCross-functional collaborationAttention to detailCommunication skills

Required

Bachelor's degree in engineering, or other related technical discipline required

4-7 of experience in a quality-related role within a regulated industry (medical device preferred)

Strong working knowledge of qualification and validation methodologies, including IQ/OQ/PQs, pFMEAs, Control Planes, Capability studies (Cpk), Gage R&R and measurement system analysis, First Article Inspections

Ability to interpret engineering drawings, specifications, and technical requirements

Strong written and verbal communication skills, including supplier-facing interactions

Preferred

Knowledge of manufacturing processes such as injection molding, PCB manufacturing and assembly, machining, and casting

Familiarity with ISO 13485 and ISO 9001

Company

Dexian

Glassdoor3.5

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

Founded in 1994

Mclean, Virginia, USA

1001-5000 employees

https://dexian.com

H1B Sponsorship

Dexian has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2025 (65)